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Flex Pharma Initiates Phase 2 Efficacy Study in Multiple Sclerosis

-- FLX-787, A Single Molecule, Synthesized, TRP Ion Channel Activator, in Randomized, Controlled, Cross-over Study --

BOSTON--(BUSINESS WIRE)--Jun. 15, 2016-- Click to Tweet this News

Flex Pharma, Inc. (NASDAQ: FLKS) today announced that it has initiated a Phase 2 efficacy study in multiple sclerosis (MS) patients in Australia. The randomized, controlled, blinded, cross-over study is designed to evaluate the safety and efficacy of FLX-787, the Company’s single molecule, chemically synthesized, transient receptor potential (TRP) ion channel activator, in approximately 50 patients who suffer from cramps, spasms and/or spasticity as a consequence of MS.

MS is an autoimmune disease in which inflammatory processes cause worsening demyelination and cell degeneration over years, resulting in a variety of neurological deficits such as loss of muscle control, sensation and vision. Spasticity is caused by damage to motor systems in the brain and spinal cord. These lesions cause hyperactive muscle stretch reflexes, which result in spasticity. The need to treat spasticity increases as the disease progresses. According to the National Institute of Neurological Disorders and Stroke, between 250,000 and 350,000 people in the United States suffer from MS and approximately 84% of patients with MS experience spasticity.

“Neurologists have very limited therapeutic options for patients suffering from MS spasticity and the current options are often suboptimal due to their associated side effects,” stated Al Sandrock, M.D., Ph.D., Biogen Chief Medical Officer and member of the Flex Pharma Scientific Advisory Board. “The approach by Flex Pharma offers a potential important advantage as the drug candidate may reduce cramps and spasms without the sedating side effects of many current therapies.”

“FLX-787 appears to have virtually no systemic exposure, thus potentially avoiding drug-drug interactions for patients on several prescription products,” said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D., who served as the medical lead for three products approved in United States: Razadyne®, Lunesta® and Ampyra®.

“We believe that Chemical Neuro Stimulation, the process whereby small molecules activate TRP ion channels topically, leads to sensory stimulation that in turn reduces hyperexcitability in motor neurons,” noted Dr. Rod MacKinnon, Nobel laureate and Flex Pharma Scientific Co-Founder, Board Member, and Scientific Advisory Board Co-Chair. “We hypothesize that this approach may be generally applicable as a treatment for cramps and spasms in a spectrum of neuromuscular conditions.”

“We are encouraged by our recent positive results with the original extract formulation in nocturnal leg cramps (NLC), and we expect to have three human efficacy studies - in MS, ALS and NLC – initiated this year with our single agent candidate, FLX-787,” said Laura Rosen, M.D., Ph.D., Flex Pharma Vice President, Clinical Research & Drug Safety. “I hope our efforts will ultimately help the many patients with severe neuromuscular diseases who suffer from these painful conditions.”

About Flex Pharma

Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps, cramps and spasms associated with severe neuromuscular conditions such as ALS and MS, and exercise-associated muscle cramps. Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Chair and CEO Christoph Westphal, M.D., Ph.D.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding future studies of our current product candidates, including the success and timing of these studies and our beliefs regarding the potential benefits of our current product candidates. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation: the status, timing, costs, results and interpretations of our clinical studies; the uncertainties inherent in conducting clinical studies, including receiving regulatory approval to conduct these studies; the fact that we rely on third parties to manufacture and conduct the clinical studies of our product candidates, which could delay or limit future development or regulatory approval; results from ongoing and planned preclinical development; expectations of our ability to make regulatory filings and obtain and maintain regulatory approvals; results of early clinical studies as indicative of results of future trials; the inherent uncertainties associated with intellectual property; and other factors discussed in greater detail under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read Flex Pharma’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Source: Flex Pharma, Inc.

Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications